Paragon Adult Maxi PMP Oxygenator
Paragon Adult Maxi PMP is a hollow-fiber membrane oxygenator for cardiopulmonary bypass in adults and small adults. It exchanges oxygen and carbon dioxide in blood and incorporates a heat…
Paragon Adult Maxi PMP is a hollow-fiber membrane oxygenator for cardiopulmonary bypass in adults and small adults. It exchanges oxygen and carbon dioxide in blood and incorporates a heat exchanger to regulate blood temperature.
Gas travels inside plasma-tight hollow fibers while blood contacts their outer surfaces, permitting diffusion across the membrane. Separate nonporous heat-exchanger fibers carry water to control the temperature of blood flowing outside them.
Listed Item
The Paragon Adult Maxi PMP oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature.
Use Duration
The oxygenator is supplied ethylene-oxide sterilized for single use and is intended for up to six hours of clinical operation. A Rheopak surface coating is included on the blood-contacting device.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifemotion Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Chalice Medical Ltd, United Kingdom |
|---|---|
| FDA product code | DTZ |
| Device type | Oxygenator, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4350 |
| Establishment | Manufacturer |
| 510(k) | K191246 |
| Record published | 2021-01-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: to be stored in a dry, room temperature area and protected from direct solar or UV Light. |
| Packaging | Box of 12 |
| Sizes | Total volume 300 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XCMOP405PMP | Total Volume 300 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oxygenator, Cardiopulmonary Bypass | Medtronic, Inc. | 1,281 |
| Intersept™ | Medtronic, Inc. | 103 |
| Inspire | Sorin Group Italia SRL | 14 |
| Capiox®fx | Terumo Corp. | 14 |
| Capiox®rx | Terumo Corp. | 13 |
| Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U | Spectrum Medical Ltd | 11 |
| Lilliput | Sorin Group Italia SRL | 11 |
| Abiomed Breethe OXY-1 System | Breethe, Inc. | 11 |
| Kids | Sorin Group Italia SRL | 8 |
| Affinity NT™ | Medtronic, Inc. | 8 |
| Affinity Fusion™ | Medtronic, Inc. | 7 |
| QUADROX-i | Maquet Cardiopulmonary GmbH | 7 |
Showing 12 of 69. All products under Oxygenator, Cardiopulmonary Bypass
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231414 | 2023-11-01 |
| K201642 | 2020-09-18 |
| K191246 | 2020-02-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.